Multiple Ascending Dose (MAD) Combination in Subjects With Multiple Myeloma

Overview

To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-833923 administered alone, in combination with lenalidomide plus dexamethasone, or in combination with bortezomib in subjects with relapsed or refractory multiple myeloma.

Full Title of Study: “A Phase Ib Multiple Ascending Dose Study of BMS-833923 Alone or in Combination With Lenalidomide (Revlimid) Plus Dexamethasone or in Combination With Bortezomib (Velcade) in Subjects With Relapsed or Refractory Multiple Myeloma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2012

Interventions

  • Drug: BMS-833923
    • Capsule, Oral, Once daily, 6 months
  • Drug: Lenalidomide
    • Capsule, Oral, Once daily, 6 months
  • Drug: Dexamethasone
    • Capsule, Oral, Once a week, 6 months
  • Drug: Bortezomib
    • Powder, IV, On days 1, 4, 8, 11, 6 months

Arms, Groups and Cohorts

  • Experimental: Arm 1
    • BMS-833923 (Starting dose is a loading dose of 60 mg for 7 days with a 30 mg daily dose thereafter)
  • Active Comparator: Arm 2
    • BMS-833923 (MTD or below) Lenalidomide (at or below the recommended prescribing dose) Dexamethasone (40 mg)
  • Active Comparator: Arm 3
    • BMS-833923 (MTD or below) Bortezomib (at or below the recommended prescribing dose)

Clinical Trial Outcome Measures

Primary Measures

  • To establish DLT(s), MTD, and Phase 2 dose range and schedule of BMS-833923 administered alone, in combination with two dose levels of lenalidomide plus dexamethasone, or with two dose levels of bortezomib in subjects with relapsed or refractory MM
    • Time Frame: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles

Secondary Measures

  • To evaluate the safety and tolerability of BMS-833923 as a single agent or in combination with two dose levels of lenalidomide plus a fixed low-dose of dexamethasone or in combination with two dose levels of bortezomib
    • Time Frame: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
  • To evaluate the Pharmacokinetics of BMS-833923
    • Time Frame: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles
  • To evaluate the Pharmacodynamics effects of BMS-833923
    • Time Frame: For Treatment Arms A and B, outcome would be measured for approximately 5 months on Days 1, 8, 15, and 28 for Cycles 1 and 2 and then every 28 days for the following cycles

Participating in This Clinical Trial

Inclusion Criteria

  • Confirmed diagnosis of Multiple Myeloma – Men and Women at least 18 years old – ECOG status 0-2 – Last therapeutic or diagnostic treatment at least 21 days prior – Bone marrow transplants must have been completed at least 3 months prior – Any toxicity from prior therapies must have resolved to Grade ≤1 Exclusion Criteria:

  • Women pregnant or breastfeeding – WOCBP unwilling/unable to use acceptable method to avoid pregnancy – Uncontrolled medical disorder or active infection – Current or recent (w/in 3 months) gastrointestinal disorder – Inability to swallow oral medication – Inability to be venipunctured – Uncontrolled or significant cardiovascular disease – Uncontrolled hyperlipidemia – Intolerance of lenalidomide or bortezomib if participating in Arms B and C – Concurrent therapy with any other investigational product – Subjects involuntary incarcerated – Subjects detained for treatment of psychiatric or physical illness

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bristol-Myers Squibb
  • Collaborator
    • Exelixis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb

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